GRAVITAS: Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety
GRAVITAS
1 other identifier
interventional
2,800
2 countries
82
Brief Summary
The objective of the GRAVITAS trial is to determine whether tailored anti-platelet therapy using the Accumetrics VerifyNow P2Y12 assay reduces major adverse cardiovascular events after drug-eluting stent implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2008
Typical duration for not_applicable
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2008
CompletedFirst Posted
Study publicly available on registry
March 28, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJune 16, 2011
June 1, 2011
2.3 years
March 24, 2008
June 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first occurrence of post-randomization CV death, non-fatal MI, or ARC definite/probable stent thrombosis in non-responders randomized to standard vs. tailored dosage
6 months
Secondary Outcomes (1)
Time to first occurrence of post-randomization CV death, non-fatal MI, or ARC definite/probable stent thrombosis in non-responders randomized to standard dosage vs. responders
6 months
Study Arms (3)
A
ACTIVE COMPARATOR"Tailored" clopidogrel regimen - an additional clopidogrel 600-mg loading dose (eight 75-mg tablets taken orally; daily 150 mg clopidogrel dose plus additional 450 mg clopidogrel) on the day of randomization and then 150-mg clopidogrel every day thereafter for 6 months.
B
PLACEBO COMPARATOR"Standard" clopidogrel regimen - a placebo loading dose (six placebo tablets taken orally plus daily dose of one placebo tablet plus 75 mg clopidogrel) on the day of randomization followed by one placebo tablet plus 75 mg clopidogrel every day thereafter for 6 months.
C
PLACEBO COMPARATORResponders: A random sample of clopidogrel responders treated with a placebo loading dose (six placebo tablets taken orally plus daily dose of one placebo tablet plus 75 mg clopidogrel) on the day of randomization followed by one placebo tablet plus 75 mg clopidogrel every day thereafter for 6 months.
Interventions
oral, 6 pill loading dose on day of randomization; one pill daily for 6 months starting on day of randomization
Eligibility Criteria
You may qualify if:
- Males or females aged 18 years or older.
- \. Patients undergoing coronary angiography and possible PCI with planned use of at least one drug-eluting stent (DES), and without planned use of glycoprotein IIb/IIIa inhibitors. One or more bare metal stents (BMS) may be implanted, and other lesions may be treated without stenting, as long as at least one DES is implanted. However, the procedure must be successful and uncomplicated for all lesions (DES + BMS + non stent).
- Indication for the procedure may be stable angina or ischemia, unstable angina, non-ST elevation MI (NSTEMI), or ST elevation MI (STEMI).
- Have the ability to understand the requirements of the study, including consent for use and disclosure of research-related health information.
- Have the ability to comply with study procedures and protocol, including required study visits.
- \. A female patient is eligible to enter the study if she is (1) of child-bearing potential and not pregnant or nursing; (2) not of child-bearing potential (i.e., has had a hysterectomy, have both ovaries removed, has tubal ligation, or are post-menopausal, defined as 24 months without menses).
You may not qualify if:
- PCI within previous 30 days.
- Prior consent to participate in GRAVITAS and not randomized by IVRS.
- History of gastro-intestinal bleeding within 6 months.
- Major non-cardiac surgery within 6 weeks.
- Ischemic stroke within 6 weeks.
- Any history of hemorrhagic stroke or sub-arachnoid hemorrhage.
- Other bleeding diathesis, or considered by investigator to be at high-risk for bleeding on long-term clopidogrel therapy.
- Minor surgical procedures that require cessation of dual anti platelet therapy and result in significant bleeding are NOT eligible.
- Current or planned therapy with coumadin anticoagulation.
- Current or planned therapy with other thienopyridine class of ADP receptor inhibitors (e.g., prasugrel, ticlopidine), or the non-thienopyridine ticagrelor.
- Severe allergy to stainless steel, contrast dye, unfractionated heparin, low molecular weight heparin, or bivalirudin that cannot be adequately pre-medicated.
- Allergy to aspirin or clopidogrel.
- Current enrollment in an investigational drug or device study that has not reached the time period of the primary endpoint.
- Have received GPIIb/IIIa inhibitors eptifibatide or tirofiban within 24 hours before or during PCI or abciximab within 10 days before or during PCI.
- Thrombocytopenia (defined as platelet count \< 100 K).
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Scottsdale Health Care - Osborn Campus
Scottsdale, Arizona, 85258, United States
Scottsdale Health Care - Shea Campus
Scottsdale, Arizona, 85258, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
El Camino Hospital
Mountain View, California, 94040, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Sacramento Heart and Vascular Research Center
Sacramento, California, 95825, United States
UCSD Medical Center
San Diego, California, 92103, United States
Alvarado Hospital
San Diego, California, 92120, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
UCSF Moffitt-Long Hospital
San Francisco, California, 94143, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Torrance Memorial Medical Center
Torrance, California, 90503, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
Christiana Care Hospital
Newark, Delaware, 19718, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, 33756, United States
University of Florida Health Science Center
Jacksonville, Florida, 32209, United States
Cardiology Research Associates
Ormond Beach, Florida, 32174, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
St. Joseph's Research Institute
Atlanta, Georgia, 30342, United States
Redmond Regional Medical Center
Rome, Georgia, 30165, United States
Jesse Brown VA Medical Center
Chicago, Illinois, 60612, United States
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Trinity Medical Center
Moline, Illinois, 61265, United States
Prairie Education & Research Cooperative
Springfield, Illinois, 62701, United States
St. Vincent Heart Center of Indiana/The Care Group LLC
Indianapolis, Indiana, 46290, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70232, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
The Lahey Clinic
Burlington, Massachusetts, 01803, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
St. Joseph's Mercy Hospital
Ypsilanti, Michigan, 48197, United States
St. Mary's Duluth Clinic Health System
Duluth, Minnesota, 55805, United States
St. Luke's / Mid America Heart Institute
Kansas City, Missouri, 64111, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Lenox Hill Hospital
New York, New York, 10021, United States
NY Presbyterian / Weill Cornell Medical Center
New York, New York, 10021, United States
Hudson Valley Heart Center
Poughkeepsie, New York, 12601, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Carolina Cardiology Associates
High Point, North Carolina, 27262, United States
Wake Heart Research
Raleigh, North Carolina, 27610, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
North Ohio Research, Ltd.
Elyria, Ohio, 44035, United States
Cleveland Cardiovascular Research Foundation
Fairview Park, Ohio, 44126, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, 73120, United States
Geisinger Clinic - Cardiology
Danville, Pennsylvania, 17822, United States
St. Vincent Health Center
Erie, Pennsylvania, 16502, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Black Hills Clinical Research Center
Rapid City, South Dakota, 57701, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
South Austin Hospital
Austin, Texas, 78704, United States
Austin Heart P.A.
Austin, Texas, 78756, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, 76104, United States
The Methodist Hospital
Houston, Texas, 77030, United States
University Hospital San Antonio (UTHSCSA)
San Antonio, Texas, 78229, United States
Tomball Regional Hospital
Tomball, Texas, 77375, United States
Royal Alexandra Hospital
Edmonton, Alberta, Canada
McMaster University
Hamilton, Ontario, Canada
York PCI Group
Newmarket, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel-Dieu
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
Montréal Heart Institute
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hôpital Laval
Québec, Quebec, Canada
Related Publications (3)
Price MJ, Angiolillo DJ, Teirstein PS, Lillie E, Manoukian SV, Berger PB, Tanguay JF, Cannon CP, Topol EJ. Platelet reactivity and cardiovascular outcomes after percutaneous coronary intervention: a time-dependent analysis of the Gauging Responsiveness with a VerifyNow P2Y12 assay: Impact on Thrombosis and Safety (GRAVITAS) trial. Circulation. 2011 Sep 6;124(10):1132-7. doi: 10.1161/CIRCULATIONAHA.111.029165. Epub 2011 Aug 29.
PMID: 21875913DERIVEDPrice MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290.
PMID: 21406646DERIVEDPrice MJ, Berger PB, Angiolillo DJ, Teirstein PS, Tanguay JF, Kandzari DE, Cannon CP, Topol EJ. Evaluation of individualized clopidogrel therapy after drug-eluting stent implantation in patients with high residual platelet reactivity: design and rationale of the GRAVITAS trial. Am Heart J. 2009 May;157(5):818-24, 824.e1. doi: 10.1016/j.ahj.2009.02.012.
PMID: 19376306DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew J Price, M.D.
Scripps Advanced Clnical Trials
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 24, 2008
First Posted
March 28, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
June 16, 2011
Record last verified: 2011-06